Clinical Trial

Treatment and Outcome of Patients With Mild Head Injury

Study acronym: BTER23
Recruiting
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Summary
The study aims to assess the incidence of complications, such as intracranial haemorrhages and neurological deficits, in patients with head trauma treated in the emergency departments of the Emilia-Romagna Region and to compare the prognostic accuracy of the Canadian CT Head Rule and NEXUS Head CT Instrument in predicting post-traumatic complications. This is a retrospective multicentre cohort study that includes patients aged 18 years or older with isolated head trauma who underwent brain CT within 24 hours of the trauma. The data, sourced from hospital databases, will include medical history, prognostic scores, instrumental examinations, pharmacotherapy and adverse events. The primary objective is to determine the incidence of complications in patients who require surgery or who die, while the secondary objectives aim to compare the prognostic effectiveness of the two instruments in predicting complications. In addition, the study will examine the management strategies adopted and seek to identify any predictors of complications not included in current prognostic models. The results will contribute to improving the management of head trauma in emergency departments and optimising the use of available prognostic tools.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2026-01-05; most recent amendment 2026-01-15.
Trial Details
NCT Number NCT07339319
Lead Sponsor Azienda USL Reggio Emilia - IRCCS
Conditions Head Injury Trauma
Enrollment 4,500 participants
Start Date 2024-02-01
Primary Completion 2025-04-01 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-16